Baricitinib, Methotrexate, or Combination in Patients with Rheumatoid Arthritis and no or Limited Prior Disease-Modifying Antirheumatic Drug Treatment
Fleischmann F, Schiff M, van der Heijde D, Ramos-Remus C, Spindler A, Stanislav M, Zerbini CAF, Gurbuz S, Dickson C, de Bono S, Schlichting D, Beattie S, Kuo W-L, Rooney T, Macias W, Takeuchi T. - Arthritis Rheumatol 2016. DOI 10.1002/art.39953. Accepted article
In this 52-week study of patients receiving initial therapy for RA, baricitinib alone or in combination with MTX demonstrated superior efficacy compared with MTX alone.
Patients naïve to csDMARD (no or <3 doses of MTX) or bDMARD were randomised 4:3:4 (N=588) to
MTX QW, baricitinib 4 mg QD or baricitinib 4 mg QD + MTX QW. The primary endpoint assessment was noninferiority of baricitinib monotherapy to MTX based on ACR20 response at Week 24.
Not only was the primary endpoint met, baricitinib monotherapy was superior to MTX at Week 24, with a higher ACR20 response rate of 77% for baracitinib monotherapy versus 62% for MTX monotherapy (P≤0.001 for noninferiority). Statistically significant improvements in the following secondary measures were also seen for both baricitinib groups versus placebo at Weeks 24 and 52: SDAI and CDAI; DAS28-CRP or DAS28-ESR; HAQ-DI. Less progression in vdH-mTSS was also seen for the baricitinib groups.
Rates of treatment-emergent AEs, including infections, were increased with baricitinib + MTX, however rates of SAEs, including serious infections, were similar across groups.
While treatment with baricitinb + MTX offered modest additional benefits over baricitinib monotherapy, there were some suggested increases in risk of certain adverse events. The findings of this study may be important for patients with a contraindication to or intolerance of MTX treatment.